Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: TERIFLUNOMIDE

• Registration Number: NCT04410965
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

Evaluate the relationship between ABCG2 mutation (rs2231142) and teriflunomide exposure, during 6-month treatment with teriflunomide 14 mg

Secondary Objective:

Characterize the safety (AEs, such as ALT enhancement, hair thinning, diarrhea, nausea, etc.) during 6-month treatment with teriflunomide

Detailed Description

Study duration per participant is approximately 28 weeks including a 24-week treatment period

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
teriflunomide	TERIFLUNOMIDE	daily oral administration of teriflunomide 14 mg for 24 weeks

Primary Outcome Measures

Name	Time	Method
PK exposure: Cmax	From Week 8 to Week 24	PK exposure Cmax will be estimated by PopPK analysis.
PK exposure: AUCtau	From Week 8 to Week 24	PK exposure AUCtau will be estimated by PopPK analysis

Secondary Outcome Measures

Name	Time	Method
Participants with Serious Adverse Events and Adverse Events	Screening to Week 24

Trial Locations

Locations (1)

Investigational Site Number; 🇨🇳 China, China